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GMP/GDP Consultative Committee
Note of Meeting 17th October 2014, Room R-T-410, 151 Buckingham Palace Road,
London.
Representatives from the following organisations were present at the GMP-GDP Consultative Committee meeting held at BPR on the 17th October 2014:
MHRA (Inspection, Enforcement & Standards Division) Scottish Lifesciences Association (SLA) Proprietary Association of Great Britain (PAGB) Bio-Industry Association (BIA) British Generic Manufacturer's Association (BGMA) Association of Pharmaceutical Specials Manufacturers (APSM) British Association of Pharmaceutical Wholesalers (BAPW) Joint Professional Bodies QP Assessor Panel (JPB-QP) Pharmaceutical Quality Group (PQG) Association of the British Pharmaceutical Industry (ABPI) Research Quality Association (RQA)
British Association of European Pharmaceutical Distributors (BAEPD) Veterinary Medicines Directorate (VMD) Ethical Medicines Industry Group (EMIG) NHS Pharmaceutical QA Committee The Cogent Group
1. Introduction
MHRA welcomed current and new representatives to the meeting. 2. Minutes of the last meeting and Matters Arising. 2.1 The minutes of the last meeting held on 11th April were agreed.
Matters Arising
2.2 Publication of GDP deficiency data
BAPW reported that it had spoken to its members and had sent some ideas on how the data could be presented for the MHRA inspectorate to take forward.
3. Agency update 3.1 Changes within MHRA
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MHRA reported as follows:
There has been a change in the Minister that MHRA are responsible to. This has changed from Earl Howe, the Health Minister, to George Freeman, the Life Sciences Minister. This is a significant change as the ministerial post for life sciences is a new post, charged with making the UK the best place for industry in terms of science, design and adoption of 21st century medicines and healthcare innovations.
The current chairman of the agency, Sir Gordon Duff, will be leaving the MHRA at the end of the year to take up a post as principal of St Hilda’s College, Oxford University. A new chairman will be announced shortly.
Dr Siu Ping Lam has been permanently appointed as Director of the MHRA Licensing Division.
The MHRA office in Welwyn Garden City has been vacated and staff have been relocated to the MHRA (NIBSC) site in South Mimms.
3.2 Changes within I,E&S MHRA explained that significant restructuring had taken place within
the I,E&S division. The three major changes are as follows:
The two inspectorate groups have been brought together as one with four different units within the group, two of which are Operations units. The remaining units are an Inspectorate Strategy and Innovation unit, and Inspectorate Risk, Control and Governance unit. There are also additional changes within these units. Changes have been made to ensure more consistent working across the group, driving forward innovation and risk-based methodologies, and providing a common strategy across the group.
The creation of a third Enforcement Investigations unit following the incorporation of the Devices Division’s enforcement team into the Enforcement group. This means the agency now has a consolidated Enforcement group looking across medicines and devices.
The creation of a new Divisional Quality Standards Function in order to drive forward the quality standards within the division.
4. Inspectorate update
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4.1 Operational 4.1.1 Inspectorate staff changes & recruitment
MHRA reported that five additional inspectors have now joined the Inspectorate. MHRA are actively recruiting to fill the three remaining vacancies within the Inspectorate, to reach its full complement.
4.1.2 Compliance Management Project (EU)
MHRA reported on the Compliance Management Project. MHRA launched a compliance management escalation process in 2013, to take proactive action in response to poor compliance which is yet to reach a level where regulatory action is warranted. The team has seen positive outcomes from this escalation process:
effective in achieving manufacturer and MAH prioritisation
particularly useful in chronic compliance cases
outcomes: – avoidance of regulatory action – minimising the risk of supply shortages as a direct result
of avoiding regulatory action, although difficult to measure As a result, MHRA presented this approach to the EMA during meetings in July and September, with a recommendation that similar principles be adopted by each national competent authority across the Community. This was received positively, and a working group will be formed to draft a compliance management procedure for the Community compilation.
4.1.3 GMDP Compliance Reports
MHRA reported on changes to GMDP compliance reports. These have been in place since the launch of the Risk-Based Inspection (RBI) process in 2009. There is an expectation that information relating to site changes and certain quality indicators are provided prior to inspection, and that significant changes are notified as interim updates. The compliance report has recently been revised, with additional sections relating to:
Background information to facilitate data integrity verification during routine inspections. Such verification may be made by:
– data governance policy – confirm access to System Administrator staff – list of principal IT systems, including any changes – number of Out of Specification investigations that
have been performed (phase I and II)
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Information on all active substances handled on site (to permit a more robust assessment of cross contamination risks)
Information on corporate activities located at the site to be inspected.
In addition to the three main changes above, the guidance notes which were previously available as a separate document have now been embedded into the compliance report itself, to make reference easier. This does give the appearance of a more detailed document, however the additional information requested for data integrity verification should already be available as existing requirements of GMP, and the embedding of the guidance is intended to give a more consistent approach to completion of the required information. Finally, the interim compliance report has been separated as a stand-alone document. The majority of these changes will be presented at the upcoming GMDP Symposium. All changes will be rolled out at the beginning of January 2015.
4.2 Providing Authoritative Information 4.2.1 Agency Symposium
MHRA reported that the GMDP symposium will be taking place on 9th – 12th December 2014 at the Novotel London West, London. In order to balance the high demand for places whilst still retaining a level of intimacy and opportunity to interact with inspectors, the same programme is being repeated on a second day for both GMP and GDP. Delegates were asked to complete a survey monkey questionnaire to identify topics of interest for the agenda. The final agenda features topics relating to recent changes to the EU GMP Guide including changes to Chapter 3, Chapter 5, Annex 15, Annex 16, the new Clinical Trial Regulations, and ‘hot topic’ issues seen on inspection such as data integrity. To date, three days of the symposium have completely sold out with only a few places available on the GMP day on 12th December 2014.
4.2.2 Publications The Orange Guide
MHRA reported on the latest revision of the Orange Guide. This is the first year that the agency are publishing an annual revision. This year the guide has been updated to incorporate changes made to European Community guidelines on Good Manufacturing Practice (Chapters 3, 5, 6, and 8) and the revised EC Guidelines on Good Distribution Practice.
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In addition there are new sections on:
the Gold Standard for Responsible Persons
MHRA Innovation Office
the application and inspection process for new licences "what to expect"
MHRA Compliance Management and Inspection Action Group
MHRA risk-based inspection programme
naming contract Quality Control laboratories on a manufacturer’s licence
a new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances to be used in the manufacture of licensed human medicines.
For the Green Guide the principle is the same. It will have revised EC Guidelines on Good Distribution Practice along with the majority of the sections listed above. In addition, there are new sections on:
UK Guidance on EU Guide Chapter 1 of GDP - Quality Management
list of persons who can be supplied with medicines by way of wholesale dealing taken from the Human Medicines Regulations 2012
EC Q&A on GDP guidelines
controls on certain medicinal products
sales representative samples
handling returns of non-defective medicinal products
reporting adverse reactions
short-term storage of ambient and refrigerated medicinal products – requirements for a wholesale dealer’s licence.
The new revisions of both the Orange Guide and Green Guide should be available from January 2015. Guidance Notes 5, 6 and 14 MHRA reported that Guidance Notes 5, 6 and 14 have been updated and published on the MHRA website. The contents have been reordered and updated where necessary and some new sections have been added e.g. GN 6 which has new sections in relation to brokering.
4.2.3 Industry-led Quality Fora
MHRA reported on its involvement at industry-led quality fora. Currently, MHRA attend a number of industry-led events related to quality issues. MHRA re-iterated that if organisations present hold a quality event and feel it would be beneficial for MHRA to have an input, MHRA would gladly consider any invitation to attend such an event.
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BGMA Quality Forum feedback BGMA presented feedback following the first BGMA Quality Forum held in June. See Annex 1.
4.2.4 GMP Deficiency Data MHRA reported that the inspectorate has been working with an industry stakeholder group over the last 18 months to review the way in which deficiency trend data is presented. The aim of this work has been to ensure that the inspectorate are providing information in a manner which is of most benefit to industry in learning from a wider deficiency data set. Some of the identified improvements, particularly in regards to greater granularity in collected data, and possible incorporation of data from other inspectorates, will require an IT solution to achieve, and the team continue to work on this development. In the meantime, and working with the data collection tools available at present, the inspectorate have compiled the report of 2013 inspection findings which implement as many requests from the group as possible within the limitations of the current data set. The 2013 trend report is now published on the website at the following link: http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con464241.pdf The report includes:
2013 trends
5 year trend of top issues: – Risk of cross contamination and quality systems issues
remain most prevalent over the 5 year period – Number of majors per inspection generally consistent – Number of critical deficiencies per inspection has increased
slightly (average of 0.08/inspection in 2008-2012; 2013 average of 0.13). This is aligned with a cluster of data integrity issues
Areas for future focus: – Data integrity – Supply chain visibility (an on-going issue, with additional
FMD requirements) – Investigation of anomalies – Contamination risks.
4.2.5 You’ll Soon Feel Better
ABPI presented an item on their GMP video ‘You’ll Soon Feel Better’. See Annex 2.
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4.3 GDP Update
MHRA reported that the GDP team still consists of 16 inspectors with three on fixed term contracts, now extended. 600 inspections were completed from January to June 2014 involving 455 companies. Deficiency statistics show 16 Criticals, 496 Majors and 1957 Others. The Criticals covered 6 companies. The inspectorate are still putting together deficiency data working with definitions based on the EU Guidance chapters as requested by BAPW. The inspectorate will present a summary of findings from the deficiency data at the upcoming Symposium and will eventually publish full information on the MHRA website. The following appear to be the most commonly observed deficiencies so far:
Implementation of an adequate Quality System using Risk Management, Change Control and CAPA principles
Maintenance of correct temperatures for storage and transportation
Transportation validation
Qualification checks on all customers
Management of Returned product A review of the deficiencies will provide a source of information by which the inspectorate can identify areas where greater guidance is required for industry as well as helping wholesalers identify opportunities to improve. The inspectorate can then respond using the Green Guide revisions and information on the MHRA website. The team continue to address stakeholders through meetings and events based around newly regulated areas. They also receive training to inspect these new types of business. Some examples include marine compliance, freight forwarders working with exporters, API storage and distribution sites, Clinical Commissioning Groups and others. Another area the team have looked at closely is desktop inspections and how these can be introduced into the GDP environment with the vast array of different types of companies which MHRA inspects. The ability to carry out desktop-based inspections is linked to the risk data available and the risk-based inspection process will be utilised to identify suitable sites. The team carried out the first such desktop inspection, which was successful in meeting the needs of the company and the MHRA.
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4.3.1 RP Gold Standard update COGENT presented on the RP Gold Standard and updates following the last meeting. See Annex 3. The Gold Standard can be found at the following link: http://www.thegold-standard.co.uk/job-details/?jobid=297
4.3.2 Process Licensing Portal update MHRA presented an update on the Process Licensing Portal - the new electronic system for submitting certain applications. See Annex 4.
4.3.3 EudraGMDP MHRA presented on the EudraGMDP database. See Annex 5. 5. QP Survey Report
COGENT presented a summary of their findings from the QP Survey Report. See Annex 6 for the summary and Annex 7 for the report itself. Following the presentation, there was some discussion about how the matter would be taken forward. JPB QP stated they would be happy to support the initiative as they had not had any input into the report so far. ABPI stated that the MMIP group intended to review the report and have invited COGENT to participate in the process.
6. International interactions
MHRA reported on the inspectorate’s recent international activities:
The inspectorate have agreed to carry out another joint training programme with WHO for the Indian state and national regulators.
The Director of IE&S recently accompanied the MHRA CEO on a visit to India to meet regulators and industry. India is a key supplier of medicines to the UK and such visits help build and maintain a good relationship.
MHRA continues to lead on the GMP project carried out within the International Coalition of Medicines Regulatory Agencies (ICMRA). There have now been six meetings. The work is progressing in two work streams: one on how countries can build a network of being able to rely on each other through the work that is done; the other looks at how information can be shared with a view to building a reliance network to negate the need for an inspection or supplementing an inspection with existing information.
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The work with the TTIP (Transatlantic Trade and Investment Partnership) continues. Workgroups have been set up by the EMA to take forward. MHRA are one of four competent authorities involved.
MHRA are looking at working more closely with the HPRA (formerly IMB) on inspections. Some MHRA inspectors are due to go to Ireland to help assist them with their Blood Programme as they currently have a shortage of inspectors in that area. They will look to reciprocate in future.
7. Falsified Medicines Directive 7.1 Safety Features
MHRA reported on the latest news regarding the delegated act for the safety features elements of the FMD. Work is underway by the European Commission to develop the delegated act, which the MHRA and DH have been heavily involved in. The latest round of Member State comments and proposals for the “black” and “white” lists will be submitted soon. MHRA expect a further Member State meeting in December followed by publication of the delegated act early in 2015.
7.2 Common Logo
The implementing act on the common logo was published in June and the provisions relating to distance selling will need to be implemented by July next year. Discussions are ongoing within the UK on how this will be implemented.
8. Feedback from the EMA
8.1 GMDP Inspectors Working Group
MHRA reported on the work of the Inspectors Working Group: Legislative changes:
Delegated act on GMP for APIs – due to be published soon.
Delegated act on GMP for IMPs as a result of the new Clinical Trial regulation:
– To be based on Directive 2003/94/EC – Commission to adopt and publish detailed guidelines in
line with those principles of GMP
Directive 2003/94/EC will be repealed, replaced or amended when 2001/20/EC is no longer applicable.
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Pharmaceuticals in the environment strategy: – Report published in June. Workshop held in September
by Commission on the development of a strategic approach to pollution of water by pharmaceutical substances.
– Pharmaceutical Committee: Commission to give presentation on state of play of the strategy to be delivered by September 2015, taking into account the study on environmental risks from medicinal products carried out for DG SANCO by BIO IS consultancy and other relevant information
Veterinary Directive 2001/82/EC to be revised.
Completed GMP updates:
Chapter 3 / 5: ‘dedicated facilities’ with improved guidance in 3.6 and 5.17-22 to prevent cross-contamination – coming into effect 1st March 2015.
Chapter 5: starting materials controls on suppliers (5.27-30, 5.35-36). Also new text 5.71 on the notification of supply restrictions – coming into effect 1st March 2015.
Chapter 8: use of QRM principles for defects / complaint investigations and for risk-mitigating actions, recall decisions and CAPAs. Also clarifies expectations and responsibilities in relation to the reporting of quality defects to the competent authorities – coming into effect 1st March 2015.
Part II: new text to link Part 17 to the forthcoming GDP for APIs – came into effect 1st September 2014.
GDP for API. The text is complete but yet to be published by the Commission.
– guidance on distribution requirements relevant to APIs based on text in GDP for finished products and in Part II.
GMP for Excipients. The text is complete but yet to be published by the Commission.
– guidance on the appropriate GMP to be applied based on a formal risk assessment by the manufacturing authorisation
– determine risk profile of excipient, document the GMP sections that need to be in place, conduct a gap analysis (audit etc) to show what is / is not in place, establish and maintain a control strategy
Ongoing GMP updates:
Annex 15: – Amend text to link with Quality Working Party guideline
on continuous process verification as an alternative to, or in a hybrid approach with, traditional process validation
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– Updated text on cleaning validation to link with changes
in Chapters 3 and 5 – Text on transport verification – Include ICH principles – Draft text been out to consultation and finalised text
expected to be agreed at December IWG – Publication expected by the end of Q1 2015
Annex 16: – Include changes to reflect increased global manufacturing
and more complex supply practices – Clarify requirements to harmonise expectations across
EU – Include ICH principles – Draft text been out to consultation and finalised text
expected to be agreed at December IWG – Publication expected by the end of Q1 2015.
Annex 17: – Broaden from current release of terminally sterilised
products to align with QWP guideline on real time release testing (RTRT)
– Include ICH principles – Main text not yet been out for consultation
Future developments:
Revision of Annex 1 – Manufacture of Sterile Medicinal Products – Complete revision to include ICH principles, improve
clarification, capture new technologies, guidance for WFI manufactured by technologies other than distillation, align with PIC/S / international requirements where possible.
Revision of Annex 13 – Manufacture of Investigational Medicinal Products
– Partial revision to incorporate requirements of CT Regulation
– CT Regulation not coming into effect until 6 months after EU portal/database is operational – expected Q1 2017
Compilation of Community Procedures to be renamed and restructured.
ATMP Report - discussed with Commission, relevant findings form the Regenerative Medicine Expert Group (RMEG) to be shared with the Commission.
– GMP IWG – subgroup formed to gather EU-wide issues based on RMEG findings - MHRA will be rapporteur.
– IWG sub-group will link with CAT on Quality issues
Starting materials for ATMPs – revisions / clarification on classification at Commission’s
Tissue CA and Blood CA
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8.2 Falsified GMP Certificates
MHRA reported that there had been an instance of a falsified GMP certificate reported to the MHRA by the Peruvian competent authority. The certificate was for a Chinese site that had allegedly been inspected by the MHRA but did not appear on the EudraGMDP database. MHRA reiterated that all genuine GMP certificates issued by the MHRA can be found on the EudraGMDP database.
9. Industry Metrics
MHRA reported that the inspectorate are looking to strengthen their RBI system using metrics obtained from industry. MHRA have met with four large pharmaceutical companies to discuss the governance systems they have and what information the agency can take from them to place more reliance on the work they do and therefore provide regulatory relief. Consideration is being given as to what metrics will help support the RBI system. MHRA reported that the FDA are launching a quality metrics programme as part of their Office of Pharmaceutical Quality (OPQ). MHRA have discussed with FDA how they expect the quality metrics programme to work and will discuss further along with EMA on how metrics programmes can be aligned.
10. Any other business
MHRA suggested it may canvass members on whether they felt there would be value in joining a wider stakeholder engagement meeting which would address common aspects across the GxPs. MHRA will discuss internally prior to contacting members on the matter.
11. Date of next meeting April 2015
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Qualified Persons (QPs) in Medicine Manufacturing
Qualified Persons (QPs) in Medicine Manufacturing .............................................................................. 1
Executive Summary: ................................................................................................................................ 2
1. Introduction ............................................................................................................................ 3
2. The Sector ............................................................................................................................... 5
3. Regulation ............................................................................................................................... 6
4. Requirements for Certification ............................................................................................... 7
5. Sponsors .................................................................................................................................. 9
6. Medicine Manufacturing Licensing and the QP workforce .................................................. 10
7. Methodology ......................................................................................................................... 11
8. Interviewee Profile ................................................................................................................ 12
9. Training Capacity ................................................................................................................... 12
10. The Assessment Process ................................................................................................... 13
11. Training and Sponsorship .................................................................................................. 13
12. Gaining Knowledge ........................................................................................................... 15
13. Gaining Experience............................................................................................................ 16
14. Direct Employment and Contract Employment. ............................................................... 19
15. The NHS ............................................................................................................................. 20
16. Investigational Medicinal Products ................................................................................... 21
17. QPs in the EU (outside of the UK) ..................................................................................... 22
18. Summary ........................................................................................................................... 23
19. Concluding remarks .......................................................................................................... 25
APPENDIX A ........................................................................................................................................... 26
APPENDIX B ........................................................................................................................................... 29
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Executive Summary:
Qualified Persons (QPs) in medicine manufacturing are responsible for certifying batches of
medicinal products prior to sale, or for use in a clinical trial. The role requires extensive experience
and knowledge in a wide range of areas, and training entails substantial financial investment. During
consultations conducted by the Ministerial Industry Strategy Group (MISG) employers reported that
they faced ongoing difficulties in filling the QP role. This was especially crucial for areas relating to
cellular therapies and tended to be dominated by smaller, higher growth enterprises. The present
study, funded by the UK Commission for Employment and Skills (UKCES), aims to determine whether
these initial findings are borne out amongst a cross section of industry.
The findings are based on qualitative semi structured interviews with 20 representatives from the
Medicine Manufacturing industry. It was found that respondents had similar experiences in many
aspects of recruitment, training and contracting of QPs.
The number of QPs and active manufacturing licences appears to be in balance. However, because
of the complexities in mapping of individuals to licences and licences to manufacturing sites it is
unclear whether this position is sustainable. All respondents said that it would be difficult to source
a QP to go directly onto their licence, but it was clear that specific areas, notably small companies,
publically funded organisations and those producing novel, niche products have particular pressures.
For example, NHS manufacturing units have difficulty offering competitive salaries, whilst
manufacturing organisations producing Investigational Medicinal Products (IMPs) struggle to locate
QPs with relevant experience in niche areas.
Knowledge and experience requirements for QP certification are particularly demanding. Some
respondents expressed dissatisfaction with the rigidity of current expectations. This was particularly
pertinent for organisations producing IMPs where trainees have to acquire a wide breadth of
knowledge, but where they may work in a specialist field for the duration of their career.
Manufacturing units producing IMPs are also more likely to rely on transitional QPs. However, with
this cohort facing retirement there is an ever more pressing need to train more QPs for IMP release.
QPs can be employed either directly or on a contract basis. It was found that contract QPs are useful
when filling peaks in demand or when working on specific projects that require specialist knowledge.
In the short term, they can also be more cost effective than employing QPs directly. Employers,
however, usually prefer direct employees, due to the benefits they confer in terms of organisational
commitment, continuity, inclusion in the management structure and cost. Despite this, increasing
numbers of QPs are opting to work on a contract basis given how significantly more lucrative this
form of employment is.
Overall, respondents reported that they felt it would be difficult to source QPs to go directly on to
their licence, although not impossible in all cases. In response to this difficulty, employers are opting
to contract QPs or train internally. The costs associated with both training and contracting QPs are
substantial and pose greater problems for smaller companies and NHS units. Stringent requirements
for experience and knowledge in the certification process are also viewed as reducing the number of
newly qualified IMP QPs, resulting in an over reliance on transitional QPs who are facing a
retirement cliff.
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1. Introduction
The production and importation of medicinal products in the UK is subject to regulatory
requirements that originate in European Union directives, and apply equally throughout the EU
member states and the European Economic Area. In 1975 the legal requirement for a Qualified
Person (QP) was first introduced (via EU directives 1975/319/EC and 1975/318/EC) with a
responsibility to certify batches of Medicinal products prior to sale.
In 2004 the EU Clinical Trial Directive (2001/20/EC) was implemented in the UK (via SI 20014:1031)
which expanded the requirement for QPs to Clinical Trial Materials (Investigational Medicinal
Products – IMP). Over the past decade, other product types have been added to the list of those
requiring QP certification, including Advanced Medicinal Therapy Products (ATMP) and Traditional
Herbal Medicines (THM). Rigorous safety regulation means that the industry is critically dependent
on an adequate supply of QPs to certify release, both in routine production and development.
Two sets of provisions of the directive have been enacted, Transitional and Permanent, with a
number of sub-categories beneath them. New entrants to the profession are covered by the
Permanent Provisions, which has a formal assessment route following criteria that are tight in
definition but broad in technical scope.
Transitional Provisions were introduced to allow the introduction of the role, and rely more heavily
on the demonstration of previous experience. In broad terms, the original certification under
Transitional Provisions requires appropriate experience to have been gained between 1975 and
1985. Significantly, this cohort is now at or close to retirement.
There are two subcategories of QPs certified under Transitional Provisions, these are:
• Transitional IMP QPs who were certified to act as Qualified Persons for Clinical Trial
materials only before May 2006
• Transitional Herbal QPs who were certified to act as Qualified Persons for Traditional Herbal
Medicines before April 2013
These QPs are restricted to the type of product for which they are certified, and cannot be named on
a different license i.e. an IMP QP can move to another IMP Manufacturers Importers Authorisation
(MIA-IMP), but cannot be named as QP on a commercial MIA.
In recent years the industry has evolved from one dominated by large generic manufacturers
towards a more dispersed landscape with an increased number of small high growth manufacturers.
The workforce however has continued to age, while the regulatory framework has become tighter.
Anecdotal evidence is now emerging to suggest that a shortage of QPs in some sectors is likely to
affect the development of the industry. This is only exacerbated by the reduction in the number of
QPs certified under Transitional Provisions.
This study was funded by the UK Commission for Employment and Skills (UKCES) as part of Employer
Investment Fund round 2 funding that was awarded to Cogent Sector Skills Council, and aims to
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understand more about the nature of the barriers to recruitment for Qualified Persons and their
distribution across different manufacturing areas.
The research is based on qualitative semi-structured interviews with 20 representatives from the
Medicine Manufacturing industry, and was prompted by consultations conducted by the Ministerial
Industry Strategy Group. Respondents in that survey reported that they faced ongoing difficulties in
filling the QP role. This was especially pertinent for areas relating to cellular therapies and tended to
be dominated by smaller, higher growth enterprises. These and similar concerns, however, have yet
to be documented in any comprehensive research studies. The purpose of this investigation was
therefore to determine if the findings from these consultations are borne out amongst a cross
section of industry.
The central research questions were:
I. What broadly is the size of the QP workforce in the UK?
II. How difficult is it to recruit or contract QPs?
III. What are the barriers to recruitment?
IV. How does the QP certification process affect the supply of QPs?
The findings in this study were based on a small number of respondents who nonetheless had
considerable and broad collective experience of the industry; as QPs, recruiters, trainers, assessors
and sponsors. Their views formed an essentially consistent picture of a sector that is today broadly
able to match QPs to licences, but with some serious difficulties for niche areas and small
manufacturing units (including within hospitals). The evolution of the industry in the UK will make
this issue increasingly acute, as the number of small units, generating innovative products, grows.
The rate at which new QPs are being certified by the professional bodies is a concern, and one only
exacerbated by the loss of Transitional QPs in the coming years. Overall, respondents reported that
they felt it was difficult, although not impossible, to source QPs to go directly on to their licence. In
response, employers have opted to contract QPs or train internally, but the costs associated with
both options are substantial.
The conclusions drawn from this study aim to establish a frame of reference that is widely accepted,
and from which more specific research can be initiated.
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2. The Sector
The Medicine Manufacturing sector encompasses distinct activities that, together with the range of
company sizes and areas of specialism, resist a homogeneous treatment. Established products,
Investigational Medicinal Products (IMPs), the contracting of production by ‘virtual’ companies to
Contract Manufacturing Organisations (CMOs), importation and exportation, direct and contract QP
relationships, and the production of Advanced Therapy Medicinal Products (ATMPs) contribute to a
complex picture.
Figure 1 represents an overall picture of the range of medicinal products that are produced within
the medicine manufacturing sector.
Figure 1
Source: Cogent
A medicinal product is any substance or combination of substances presented as having properties
for treating or preventing disease in human beings. Or, any substance or combination of substances
which may be used or administered to human beings with a view to restoring, correcting
physiological functions by exerting a pharmacological, immunological or metabolic action, or to
making a medical diagnosis1.
Within the broad definition of medicinal products, we will mainly refer to standard pharmaceutical
products, investigation medicinal products and advanced therapy medicinal products.
Pharmaceutical Products
Companies producing pharmaceutical products, manufacture, fabricate, and process raw materials
into pharmaceutical preparations for human and veterinary uses. Finished products are sold in
various dosage forms including, for example, tablets, capsules, ointments, solutions, suspensions,
and powders.
Investigational Medicinal Products
1 European Union, Directive 2004/27/EC, (Brussels: Official journal of the European Union, 2004)
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Investigational Medicinal Products are active substances or placebos being tested or used as a
reference in a clinical trial. This includes products that already have a marketing authorisation but
used or assembled in a way different from the authorised form, or when used to gain further
information about the authorised form2.
Advanced Therapy Medicinal Products
Advanced Therapy Medicinal Products are ‘innovative, regenerative therapies which combine
aspects of medicine, cell biology, science and engineering for the purpose of regenerating, repairing
or replacing damaged tissues or cells3
Within the sector there are also varying types of organisation, some of which are defined as follows:
Contract Manufacturing Organisations
A Contract Manufacturing Organisation is an organisation that serves the pharmaceutical industry
and provides clients with comprehensive services from drug development through to manufacturing.
NHS Manufacturing Unit
Pharmacy Departments within NHS Trusts often contain NHS Manufacturing Units that manufacture
high quality medicinal products to support clinical care within the NHS.
3. Regulation
The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Veterinary Medicines
Directorate (VMD) are the licencing authorities for medicine manufacturing in the UK, responsible
for validating the inclusion of QPs on Manufacturing and Importation Authorisations. The
manufacturing licences of interest here are:
Figure 2
Medicinal Product Licences
Human products Requires QP
MIA
Manufacturer’s/importer’s
licence
• manufacture and/or assemble (package)
medicinal products
• wholesale deal licensed medicinal
products imported from countries
outside the EEA
YES
MS
Manufacturer 'specials' licence
(No Qualified Person required)
• manufacture unlicensed medicinal
products (commonly referred to as
'specials')
• import unlicensed medicinal products
NO
2 European Union, Directive 2001/20/EC, (Brussels: Office Journal of European Communities, 2001)
3Advanced Therapy Medicinal Products FAQs
http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/tissueandcellsforpatienttreatment/atmpre/advancedtherapym
edicinalproductsfaqs.cfm (checked 8th July 2014)
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from outside the EEA
MIA(IMP)
Manufacturer investigational
medicinal products
• manufacture investigational medicinal
products used in clinical trials
YES
Veterinary products
ManA
Manufacturer’s/importer’s
authorisation
• manufacture and/or assemble (package)
medicinal products
• wholesale deal licensed medicinal
products imported from countries
outside the EEA
YES
ManSA
Manufacturer 'specials'
authorisation
• Allows the holder to manufacture
unlicensed medicinal products
(commonly referred to as 'specials')
NO
Source: MHRA
The MHRA and the VMD have given authority to three professional bodies, (the Royal
Pharmaceutical Society, the Royal Society of Chemistry and the Society of Biology) to operate an
assessment procedure for their members. This determines an applicant’s eligibility for nomination
on a company Manufacturer’s Authorisation. The relevant licensing authority is responsible for the
final decision to accept, or reject, the nomination.
4. Requirements for Certification
Candidate QPs must be sponsored by an existing QP who is a member of one of the professional
bodies. To begin the assessment process, an application is made along with the sponsor’s report. If
these are judged to be compliant with the study guide, the candidate is invited to a viva
examination.4 The oral assessments are conducted by a panel of assessors drawn from all three
professional bodies5.
The QP Study Guide sets out the legal requirements for knowledge and experience that potential
QPs must have in order to qualify, and serves as a de facto training standard. The knowledge
requirements include three foundational knowledge elements, namely pharmaceutical law and
administration, the role and professional duties of a Qualified Person, and Quality Management
Systems6. Additional knowledge requirements include mathematics and statistics, medicinal
chemistry and therapeutics, pharmaceutical formulation and processing, pharmaceutical
microbiology, analysis and testing, pharmaceutical packaging, active pharmaceutical ingredients and
investigational medicinal products7.
4 RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 3.
5 RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 4.
6 RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 4-6.
7 RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 7-11.
Page 8 of 29
These Study Guide sections are based on the minimum educational requirements for the Qualified
Person laid down in the current EU Directive 2001/83/EC Article 49 (Human) and EU Directive
2001/82/EC Article 538:
An applicant must have at least two years of relevant practical experience (one year for pharmacists)
in one or more of those activities embraced by the term QA and in premises licenced for
manufacture of medicinal products. As defined in paragraph 3 of the relevant articles above:
8 EU Directive 2001/83/EC http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons/dir2001_83_cons_20081230_en.pdf
(checked 8th July 2014)
Page 9 of 29
Although the EU Directive uses the terminology ‘qualitative analysis of medicinal products, of
quantitative analysis of active substances’ the UK has interpreted this broadly to include all QA
activities.
The MHRA advises that practical experience gained on establishments that only have a Specials
licence9, as opposed to a full Manufacturing Import Authorisation will not count toward the
fulfilment of the one/two years of experience. An applicant must be able to demonstrate a thorough
core competence in the manufacturing processes and the quality management systems involved in
the production, testing, batch release and approval for sale of the products made under the
Manufacturer’s Authorisation under which the applicant is claiming their qualifying experience.
Applicants need to satisfy examiners through the application form that they meet the knowledge
and experience requirements set out in the study guide. The applicant then undergoes, as part of
the viva, detailed questioning of their knowledge of quality management system principles. Scenario
questions are also used to test whether they are able to logically articulate an approach to a
practical situation with which they are unfamiliar10
.
It must be noted that, providing a candidate satisfies all of the requirements of the legally mandated
education and work experience requirements, and can demonstrate sufficient knowledge and
experience of the requirements set out in the UK QP Study Guide (via Application form and Viva),
there is no mandatory requirement for any additional classroom training for Qualified Person status.
But most people who approach training for QP status in the UK do some classroom training to ‘top
up’ areas that may not have been covered in their previous academic study or work experience.
5. Sponsors
The sponsor fills an important role and their support provides the first measure of the candidate’s
suitability. The position needs to be held by an experienced QP, with good contacts within the
industry and “a wide view of the pharmaceutical business from Research and Development through
Production to Marketing and Distribution”11
. They are expected to assist in organising a programme
9 For the supply of unlicensed medicinal products for individual patients
10 RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 11-12.
11 RPS, RSC & SB, Qualified Persons in the Pharmaceutical Industry, Guidance Notes for Applicants and Sponsors, (London: RPS, RSC, SB,
2013).
Page 10 of 29
of practical experience and help in “exposing the applicant to external influences”11
including
contractors, distributors, customers and others.
Ultimately the sponsor is required to provide an objective assessment of the applicant’s knowledge
and personal attributes, as well as confirming that the applicant has gained the necessary
experience. Inaccuracies in the report may be regarded as professional misconduct. While being
important in maintaining the high quality of QPs, the identification and engagement of an
appropriate sponsor is seen by many as an additional challenge for employers facing a shortage of
QP expertise.
6. Medicine Manufacturing Licensing and the QP workforce
This paper aims only to give a broad and generally qualitative description of the supply of, and the
demand for, QPs. The following data is included to give indication of the size of the workforce and
require further work to be developed into a quantitative study.
The number of sites, licenses and QPs recorded by the licensing authorities in April 2014 are given in
the table below:
Figure 312
12
Medicine and Healthcare Products Regulatory Agency, Private Communication, April 2014.
April 2014
MIA 628
MIAIMP 382
MS (No QP) 524
ManA 143
ManSA (No QP) 59
Total Unique sites 1015
MIA 307
MIAIMP 188
MS (No QP) 291
ManA 60
ManSA (No QP) 22
Total 868
MIA 587
MIAIMP 409
Veterinary ManA 151
Total Individual QPs 785
Qualified Persons
Human
Data Supplied by MHRA
Sites
Human
Veterinary
Licences
Human
Veterinary
Page 11 of 29
Each licence may relate to more than one site. Equally, more than one QP may be named on each
licence in order to provide a degree of contingency, or to align with particular business structures.
There is no hard limit on the number of licences on which a particular QP is named, although the
regulator requires the case to be made, with concern rising as the number exceeds 7 or 8. Each case
is taken on its merits and factors in the QP’s experience.
The ratio of the number of licences requiring a QP to the number of QPs actually identified on
licences is approximately 1:1.4. This suggests that the number of QPs and active licences appears to
be balanced. However, given the complex mapping of individuals to licences and licences to sites it is
difficult to draw useful conclusions from this data alone, suggesting that further research in this area
may be helpful.
Of the 785 active QPs we estimate that 30% to 50% are currently registered under the Transitional
arrangements that applied to workers already in release certification roles, or studying in a related
area, in the late 1970s and early 1980s. Significantly, this cohort is now close to retirement.
Data from the publically available portion of the Royal Society of Chemistry QP register show that
50% of those listed were registered by the RSC before 1997, 45% have been listed for more than 20
years and 20% for more than 30 years. These figures may include those who are not now active, but
points to an ageing population.
7. Methodology
Cogent was assisted in the initial scoping of the research by a contact group made up of industry and
regulatory agency representatives. These representatives provided background contextual
information and commented on draft interview questions. An email inviting individuals to take part
in the study was distributed by members of the contact group to their associates. Invitation to take
part in the study was therefore not made on the basis of a systematic selection process, and
agreement to take part in the study was based on self-selection of participating individuals. Self-
selection may introduce an element of bias to the study, as those who have had difficulty sourcing a
QP may be more likely to volunteer to participate than those who have experienced little difficulty.
20 participants (including 2 from the same organisation who were on the same telephone call)
agreed to take part in semi-structured telephone interviews. Semi-structured interviews were
selected as the most appropriate method, in order to obtain detailed descriptive information from
participants that is specific to their own experiences. This method also allows respondents to
expand on issues that are of particular relevance, whilst providing a degree of comparability through
the structured aspects of the interviews.
The interview questions were designed around the following broad research questions:
1. What broadly is the size of the QP workforce in the UK?
2. How difficult is it to recruit or contract QPs?
3. What are the barriers to recruitment?
4. How does the QP certification process affect the supply of QPs?
Page 12 of 29
All interviews were recorded and transcribed verbatim. Interview responses were then coded and
grouped thematically on the basis of applicability to the evaluation objectives, as well as on the basis
of themes that emerged throughout the interviews.
The themes emerging from the interviews will be discussed in this report and are as follows; training
capacity, the assessment process, training and sponsorship, gaining knowledge, gaining experience,
direct and contract employment, the NHS, investigational medicinal products & QPs in the EU. The
report will then draw on these discussions to revisit and provide answers to the research questions.
8. Interviewee Profile
The names of interviewees and their organisations have been anonymised in this research.
Appendix A provides the descriptive names that have been ascribed to the interviewees cited in the
study and a brief description of their organisation.
Overall, respondents were drawn from four main groups; the NHS, Industry, QP Consultants and QP
Training Providers. The types of pharmaceutical activities that these organisations are involved in
can broadly be grouped into three main areas; those working in novel biologics that produce IMPs
for clinical trials, those working as part of large pharmaceutical companies whose products range
from tablets and creams to IMPs, and Contractors and Trainers who work across the sector. Out of
the 16 Industry and NHS organisations that provided respondents for interview, 7 were SMEs and 9
were larger organisations. In addition, 2 consultancies and 2 training provider also provided
interview respondents. In total these organisations have 52 directly employed and 15 contract QPs
named on their MIA, as well as 13 trainee QPs.
The respondents themselves were drawn from a range of different job roles, including 7 QPs, 2
Consultants, 2 Heads of Production, 1 Director of Compliance, 1 QP Assessor, 2 Directors of Quality,
1 Chief Operating Officer, 1 Managing Director and 1 Head of HR and 2 QP Trainers.
9. Training Capacity
While classroom based learning is not explicitly required it is generally included in the training
programme, with one training consultant estimating that it applies to 90% of candidates. At the time
of writing the providers supplying the majority of teaching (there may be others) are:
• Reading Scientific Services Limited (RSSL)
• School of Pharmacy, University of Brighton
• NSF-DBA
• Q3P, University College London
The cost of training was cited as a barrier for companies where margins are tight and training
budgets of manufacturing units may be limited. Typically this is of the order of £10,000 per year for
around three years, in the context of a viva success rate of 60-65%. If increased to 100%, only an
Page 13 of 29
additional 24 passes per year would be achieved, all other factors being equal. The pass rate does
seem to have general dissuasive effect on potential candidates risking a large professional and
financial investment.
There is no clear evidence of a serious shortage of training capacity, at least for demand close to
current levels. The anticipated addition of new training providers is likely to have the beneficial
effect of depressing training costs.
10. The Assessment Process
A written application to the QP assessors is accompanied by the Sponsor's report. These are first
checked for compliance with the study guide by the assessors of the applicant's professional society.
If accepted the candidate is invited for interview. The application and Sponsors report is then fully
reviewed by the assessors and a viva-voce conducted against the study guide.
Over the decade to 2013 an average of 44 vivas were held each year. In the last few years the pass
rate has been below 65%. The increasing complexity of the industry has been suggested as one
cause of the recent small decline, particularly given the testing process is broad, encompassing more
than the candidates focus work area. However, there is also a feeling that "[M]any trainees receive
much less support from their companies and their Sponsors [than previously]"
11. Training and Sponsorship
Direct recruitment of a registered QP is in principle the most straightforward route to fulfilling the
regulatory requirements. Nevertheless, training is critical to the sustainable supply of QPs in the long
term, and in many cases may be the only practical route to filling a role in a small company or
specialist area. However, both the expense of QP training courses and the sourcing of a suitable
sponsor can present barriers to the number of trainee QPs emerging.
Respondents reported that for many years the large cohort of QPs registered under the transitional
arrangements had removed the urgency for companies to support specific training and succession
planning. Since many Transitional QPs are now approaching retirement, supply pressures are
beginning to increase, with an early signal being wage inflation. In general, sponsors were reported
to be difficult to find. The responsibilities of the role of the sponsor are great with the only obvious
advantage to the sponsor a shared workload if and when the candidate becomes eligible for
inclusion on a manufacturing or importation authorisation. With the financial draw of contract work
for the successful trainee, even this can be short lived.
The role of the QP requires someone with fastidious attention to detail, but who can also negotiate
effectively with senior staff to make crucial decisions. A QP must also be able to exercise the right
combination of caution and assertiveness, as well as the ability to process lots of complex
Page 14 of 29
information. This combination of qualities can be hard to find itself, but good sponsors are also
required to mentor good candidates in order to develop these qualities.
Some respondents reported that as well as difficulty in locating sponsors, many lack awareness of
their responsibilities, and in turn, do not engage fully in the process. It was suggested by two
respondents that part of the difficulty comes from the fact that sponsors are selected on a voluntary
basis and that the requirements contained within the ‘Guidance notes for Applicants and Sponsors’
are not stringent enough.
One QP said that the guidance does not emphasise the responsibility and the seriousness of the
position to a sufficient extent. They also said that the sponsors should be more involved in the
assessment process.
‘I think the information from the Society is there, but I don’t think it pushes the responsibility of the
sponsor role and the seriousness of the sponsor role enough. I think it should be more clearly stated,
this is your responsibility to put these people through when and only when they’re ready.’
It is important to note that the ‘Guidance notes for Applicants and Sponsors’ do provide a
reasonable amount of detail regarding the sponsor’s role. For example, it is highlighted that
sponsors have a duty to the applicant, the applicant’s employer, the inspection authority, their own
professional body and the general public. It also says that the sponsor should act as a guide or
mentor and this should take place over a period of two years, amongst other requirements13
. A QP
training consultant did say that in her experience there is a problem with sponsors not actually
reading the guidance notes until the end of the training process, resulting in some cases where
sponsors have actually resigned of their responsibilities upon realising what the role actually
involves. The distinction being drawn is that the obligations of a sponsor are not mandatory and that
guidance notes can be ignored or not fully understood. Some responses reflect the desire for
increased formalisation of this position, but clearly this may serve to increase the difficulty of
sourcing a sponsor in the first place, suggesting that a solution to the problem will not be a
straightforward one.
Training takes from three to five years, and can cost from £30,000 to £50,000 for the complete class
room based learning component. As a consequence there are both professional and financial
pressures to pass at the first attempt. This may make the role less attractive to otherwise good, but
often risk-averse, candidates. While training capacity does not seem to be a restriction, with
providers adding and removing courses in response to demand, cost is frequently cited as a
significant barrier. Employers are reluctant to invest in training and sponsoring potential QPs, as
there is a high prevalence of newly certified QPs leaving the business as soon as they qualify. This
has resulted in some employers introducing a claw back system to incentivise QPs to stay with the
business for a specified time after qualifying. Some employees have also found that there is little or
no investment in QP training and have become self-funding for the programme, thus giving
employers even less incentive to fund training places.
13
RPS, RSC & SB, Guidance notes for applicants and sponsors, (London: RPS, RSC, SB, 2013).
Page 15 of 29
Overall, there may be significant barriers to the number of trainees who are able to reach QP
certification, presented by the expense of QP training courses and the ability to source a suitable
sponsor. This study has found that employers can be reluctant to invest in training due to the risk
of newly certified QPs leaving the business. Sponsors can also be difficult to source due to lack of
incentives and confusion about what the role actually involves.
12. Gaining Knowledge
As detailed earlier, the knowledge requirements contained within the Study Guide cover a wide
range of pharmaceutical activity. Candidates must satisfy that they have this breadth of knowledge
through the completion of the application form and to some extent through their viva. Some
respondents felt that the knowledge requirements contained within the study guide covers too
broad a range of pharmaceutical activities than is necessary. This was particularly pertinent for
those manufacturing IMPs, where potential QPs would be expected to have in-depth knowledge of
tablets, creams, intravenous infusions, etc. when they will never come into contact with these
activities in their day job. This requirement can be a sufficient deterrent for those working in IMPs to
attempt qualify as a QP, given that they will have to acquire sufficient knowledge and experience in
areas outside of their usual remit and this may be considered time consuming and laborious.
The QP for the novel IMP manufacturing unit said that ‘I’ve personally always felt that it’s
inappropriate to have an expectation that a QP can cover all aspects of pharmaceutical drugs, from
tablets, creams through to intravenous infusions.’
The QP from the contract manufacturing facility that produces IMPs who had sponsored a colleague
through process also said that:
‘In terms of the actual qualifications, to go through all of those modules, and then he may be a QP in
a small IMP site for the rest of his life, but he’s had to do biologicals. He’s had to do commercial. He’s
had to do importation. To have to know everything at the time that he did his viva and even other
formulations that he would never do he had to know about. So clearly he’s spent a whole lot of his
valuable time swotting up, he’ll go in pass the viva, come away and he won’t even think about it
again.’
The Director of Compliance also questioned whether it is necessary to have the required level of
knowledge in all of the specified areas. He also added that the level of theoretical knowledge is not
always necessary compared to the ‘real experience you need to be able to make a decisions as a QP.’
It is important to note that the Study Guide specifies that when applicants undergo the VIVA they
will be expected to demonstrate their knowledge by reference to the products and processes
operating under the Manufacturer’s Authorisation under which they have claimed their qualifying
experience14
. This means that the majority of the VIVA will focus on an applicant’s area of expertise.
That being said, assessors may also ask questions relating to other activities or functions meaning
14
RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 12.
Page 16 of 29
that candidates will have to prepare for this aspect of questioning. Applicants also have to
demonstrate understanding of all of the additional knowledge requirements in their application
form. Presumably, it is these requirements that respondents feel are overly broad for IMP QPs.
One possible suggestion would be to allow for something close to bespoke training and assessment.
By focussing on formal training and operational experience relevant to a particular QP post, there
may be benefits in reducing formal training costs, reducing cost and difficulty in obtaining
operational experience, improving the attractiveness of the role to potential candidates and a
reduction in the time it would take to qualify. This line of thought is pursued further on in the report.
An objection to this point of view came from the QP Training Consultant. She said that technical and
academic knowledge from a wide background is required, as the QP is often the recipient of vast
amounts of data and must be able to critically assess this in order to make a decision. She also said
that the wide ranging knowledge requirements were also important to produce all round QPs who
are capable of being employed by any employer, irrespective of the QP's background.
There is clearly scope for difference of opinion relating to this matter, and viewpoints will largely be
influenced by the respondents own role, company and area of expertise. Respondents in this study
clearly saw the requirements as inflexible to those on the ground who are trying to fill QP positions.
However, those looking at the issue from a training/regulatory perspective may have more interest
in the overall need to have an adequate number of QPs certified in such a way that they are able to
fill any QP position. The conflict here is between those taking an overarching view of the sector and
those who face the practical difficulties of filling positions within their own organisations. The
complexity of working within limited resources on innovative and fast changing medicinal products
should not be underestimated, and a regulatory position that does not take their unique position
into consideration may be untenable going forward. That being said, regulators have responsibility
for keeping the public safe and so a convergence of the two positions will have to be reached in
order to ensure there are adequate numbers of QPs able to certify vital IMPs.
Overall, some respondents have expressed dissatisfaction with the rigidity of the knowledge
requirements contained within the Study Guide. It was felt that it is unnecessary for trainee QPs
to acquire such a wide varying breadth of knowledge when they may work in a specialised field for
the duration of their career. This issue was felt to be particularly impactful in the area of IMPs. In
contrast to this viewpoint, it was pointed out that the wide ranging knowledge requirements were
also important to produce all round QPs who are capable of being employed by any employer,
irrespective of the QP's background.
13. Gaining Experience
QP applicants must have at least two years of relevant experience in one or more activities
embraced by the term QA and in premises licenced for manufacture of medicinal products. See
above. Trainee QPs are also required to have a good all round appreciation of other products and
dosage forms, as a QP assessor must be confident that an applicant will be able to function as a
Page 17 of 29
Qualified Person in any licenced undertaking15
. This may require experience gained at other
manufacturing sites, in addition to the mandated 2 year experience. Interview responses indicated
that gaining the required experience, both mandated and non-mandated, was one of the main
obstacles for potential QPs in gaining certification. The reasons for this included the loss of the
manufacturing base in the UK and requirements that experience be completed on a full MIA site.
The MHRA requirement that the mandatory 2 years of experience must be gained on a full MIA
licence and not a Specials licence may be causing particular difficulty for NHS candidates. Although
experience in a Specials unit can be cited on an application form and so is useful in this respect, it
cannot be counted as legally mandated experience. This therefore reduces the amount of NHS units
that candidates can access to complete their certification requirements.
The experience requirements may also lack flexibility in a way that is particularly disadvantageous to
smaller organisations. The Head of Production for a novel biologics manufacturing unit said ‘we had
thought of doing this (putting through QP training) with the production manager, but I think at the
current time there was a belief that they needed to have worked in a quality role for two years. So, a
very useful and good production manager you’re pushing into a quality role for two years to tick a
box, not that I think it would have necessarily gained her any more experience than she’d already
got. I mean she’s already more than used to working with the quality systems.’ It was her assertion
that in small organisations, employees who are not necessarily in quality roles have a wide exposure
to quality systems, in a way that may not occur in large pharmaceutical companies. It may therefore
be unnecessary for them to occupy actual QA roles in order to gain the desired experience.
Some respondents identified the ability to travel to other manufacturing sites as a good way for
trainees to gain an all-round appreciation of other products and dosage forms. However, QP
Consultant A said that he didn’t think trainees were exploiting their networks to visit other units and
experience other quality systems, whilst the Director of Compliance said that they as an employer
need to do more to assist their trainees with visiting other sites to gain the required experience.
This implies that although there are difficulties in the acquisition of work experience, sufficient effort
on the behalf of the trainees and their employers can overcome barriers. That being said, external
factors were also found to play a part. Both QP Consultant A and the NHS Assessor said that the
erosion of the manufacturing base in the UK exacerbated the difficulty in obtaining experience.
In general, people would be expected to have gained considerable experience in the pharmaceutical
industry before being identified as a QP trainee. In fact, the 2 years of required experience was
considered to be an absolute minimum, with 4 respondents reporting that they would expect a QP
to have much more than this. One of these interviewees did not provide an actual specified period
of time, whilst two said they would expect around 5-6 years of experience, and one went as far as to
say they would expect a QP to have 10 years of experience. There is clearly the potential for great
variability in preferences for levels of experience and these are just a few examples. However, what
this does indicate is that employers may judge QPs to require fairly substantial levels of experience.
The range of experience expected by employers is also fairly expansive.
15
RPS, RSC & SB, Study Guide (London: RPS, RSC, SB, 2013), 12.
Page 18 of 29
Director of Quality for a compact packager company said that he would ‘prefer the person to be
more mature, to have maybe 5 or 6 years’ experience in our industry, in pharmaceuticals. To perhaps
have moved around within that industry to perhaps understand the various functionalities in
manufacturing, packaging, testing and QA. So they’re a rounded person. They must understand
most of the aspects of industry and be able to make decisions within industry, not somebody from an
operational level or a junior level, but someone from a more senior management level who can
actually make a decision.’
Similarly, Director of Compliance for a large pharmaceutical company, said ‘I think you really need a
good working experience in operational facilities and there’s often quite a lot of focus put on the
laboratories, but where the real issues occur is in the operational areas, particularly if you’re dealing
with things like sterile products, you’ve really got to understand the microbiologists view, the
engineers view, the production operations view to get a rounded opinion and you need experience in
those areas and the only way to get that experience is to roll up your sleeves up and get in there.
Certainly the people we’re putting through at the moment I would expect them to have in excess of 5
years’ experience.’
These comments provide a flavour of the extensive practical experience that employers judge QPs to
require. Now, these are not viewpoints taken from assessors themselves and so it could be argued
that it is the opinion of those who will be certifying QPs who matter in these circumstances.
However, the comments above come from those who will be either selecting individuals to go
through QP training and sponsorship, or those who will employ QPs directly on to their licence. This
means that their opinions about the stringency of experience requirements can directly influence
the number of QPs that are firstly, able to be put through the training process and secondly, able to
actually be employed as a QP on a site.
At first glance, these findings may appear in direct contradiction to the findings in the ‘Gaining
Knowledge’ section, in which respondents talked of the rigidity of the knowledge requirements and
how these were hampering their efforts to source IMP QPs. Responses in relation to experience
requirements, however, expressed a need for QPs with an extensive range of experience and so this
begs the question as to why respondents are so concerned regarding the extensive knowledge
requirements. This may be a consequence of the way differing interview questions can generate
different responses on similar topics. However, it may be that the knowledge requirements are
associated with having to take numerous academic courses as evidence of understanding, whereas
what employers really value is actual real life experience.
Overall, this study has found that the required experience (both mandated non mandated) to
reach QP certification can be difficult to acquire for both reasons internal to the organisation, i.e.
lack of effort/knowledge on behalf of employers/trainees, and for reasons external to the
organisation, i.e. lack of manufacturing sites and MHRA requirements. This study also found that
those employing trainee and certified QPs require an extensive range and length of experience,
which could potentially have an effect on the number of suitably qualified QPs that are available
to fill positions.
Page 19 of 29
14. Direct Employment and Contract Employment.
The role of the Qualified Person (QP) is often fulfilled by a contract employee within an organisation.
The MHRA inspectorate will determine whether the contractor is suitable to appear on an
organisation’s MIA or MIA (IMP), and the QP, including contractors, must be readily available to
perform the role of the QP permanently and continuously (2001/83/EC Article 48 & 2001/82/EC
Article 52). In general, this research found that Contract QPs are used to fill peaks in demand or to
work on specific projects that require specialist knowledge. Generally, however, direct employment
is preferred because of the benefits it confers in terms of organisational commitment, continuity,
the possibility of inclusion of the QP into the management structure, and cost.
Two respondents reported that contractors are sometimes used for work on niche products that are
outside the expertise of their directly employed QPs.
QP for a Contract Manufacturing Facility said that ‘one of our other sites have used contract QPs but
that’s in the area of biologicals because it’s outside of their area of expertise. So if they’ve had a
project that they’ve done for a client and it’s got anything to do with biological, they contract that
out to a contract QP.’
This was supported by QP Consultant A who said that contractors can be used when dealing with
niche areas, such as Advanced Therapy Medicinal Products (ATMPs), as these are outside of the
traditional QP model.
Flexibility to cover specific projects was seen as a major advantage, as this enabled cost effective
employment of contractors for short periods of time when demand was high. One QP explained that
if there is a reasonably small level of work to do then employing a contractor is preferable to
employing a full time QP on a salary.
That being said, contractors employed on a full time basis are much more expensive when compared
to directly employed QPs. Therefore, employers who demand continuous QP services, but are
unable to source directly employed QPs due, for example, to lack of available experience, are forced
to pay high rates for contractors to fulfil the role. Some respondents also commented that it is still
necessary to put contractors through relevant training to ensure they are familiar with the particular
dosage forms, which further increases the expense.
The responses given clearly indicate that contractors offer both a useful and valued service in
covering peaks in demand or when expertise is required in niche areas. However, some respondents
claimed that their use of contractors was not solely predicated on these advantages, but also on an
inability to source appropriately experienced directly employed QPs. The Head of Production for an
NHS manufacturing unit reported that they have used contract QPs for the last 5 years out of
necessity, up until the point that one of their trainee QPs qualified. This is not to say that these
organisations would forgo using contractors completely, but that they are led to a position where
they solely rely on contractors, or they employ a greater number of contractors than their
preferences would dictate. It was expressed by all the respondents that to varying extents it would
be difficult to source a QP to go directly on to their licence, further suggesting that contracting QPs
may be out of necessity.
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Other disadvantages noted were that contractors can lack organisational commitment and loyalty,
they cannot be included in the management structure, and that they can require a similar
investment to direct employees without conferring the benefits.
It is also to important note, that increasing numbers of QPs are opting to work on a contract basis
due to the financial incentive, which maybe exacerbating the problem. It was expressed by some
respondents that bigger companies are encouraging the use of contract QPs as it allows them to
keep employees off their books. Smaller companies are then disadvantaged in the sense that they
have no choice but to opt for expensive contractors, whilst being unable to source a directly
employed QP.
Overall, contract QPs are useful when filling peaks in demand or when working on specific projects
that require specialist knowledge. In the short term, they can also be more cost effective than
employing directly employed QPs. However, employing contract QPs may also be a necessity due
to the inability to source a directly employed QP. Employers usually prefer direct employees, due
the benefits they confer in terms of organisational commitment, continuity, the possibility of
inclusion of the QP into the management structure, and cost.
15. The NHS
NHS manufacturing units may face a particular set of barriers to sourcing and retaining QPs. NHS
respondents reported that the inability to offer a competitive salary was preventing the NHS from
attracting suitable QPs. This problem mainly stems from underestimates in salary banding and
general budget constraints.
Two respondents (The NHS Assessor and the Head of Production) from the NHS claimed that the QP
role is not recognised in NHS pay scales, and consequently QP salaries are simply not competitive
enough to attract those working in Industry. The QP from the blood, tissue and organs NHS unit also
said that their recruitment decisions were limited by budget constraints. It was reported that part of
the problem has arisen because the responsibility and the role of a QP is simply misunderstood by
those grading the position, resulting in an underestimate of salary. Now, this would imply that a
simple solution would be to increase knowledge within the NHS, in order to increase the salary to
one that is more competitive. However, it was also noted by the Head of Production that salaries
generally are being squeezed due to current financial constraints, implying that uncompetitive QP
salaries are part of a more widespread trend within the public sector. In turn, this may mean that
the difficulties associated with sourcing a QP are more long lasting.
Interestingly, the Head of Production said that they had not actually attempted to recruit a QP
directly on to their licence, because there was the presumption that they would be unable to attract
someone from industry, for the reasons detailed above. Caution, therefore, may have to be
exercised as there is no actual evidence, in this case at least, that their presumptions are grounded
in fact. Difficulty in offering a competitive salary was also mentioned by the contract manufacturing
facility QP as a recruitment obstacle, indicating that the issue may not be limited to the NHS alone.
That being said, nearly all of the NHS respondents (3 out of 4) cited this as a major barrier, whereas
Page 21 of 29
this issue was not reflected anywhere near so broadly in industry, suggesting that the issue maybe,
at least, more particular in the NHS.
A process of internal contracting between NHS trusts helps the problem to some degree.
Nevertheless many of the general issues associated with contract employment; exclusion from the
management structure, continuity and availability for product development, remain. The option
pursued by those in the NHS (cited by 3 representatives in this study) is to train QPs internally.
However, it was also reported that there are difficulties retaining QPs post certification, which
means internal succession planning goes only some way in solving the supply problem. Poor
retention of newly qualified QPs was reported by industry at large and so is perhaps not solely
limited to the NHS also.
Overall, representatives from the NHS report budget constraints and uncompetitive salary
banding as their main barrier to sourcing a directly employed QP. This issue was also mentioned
by one representative from industry, which implies that the problem may not be exclusive to the
NHS. However, the issue was identified by a greater proportion of NHS respondents, suggesting
that the problem may be at least more particular in the NHS. To deal with the difficulty in sourcing
QPs, NHS units normally opt to train QPs internally, but retaining QPs post certification can also
prove problematic.
16. Investigational Medicinal Products
Organisations producing investigational medicinal products for clinical trials are often working on
cutting edge and novel areas of biologics, such as cell and gene therapies. These organisations can
often find it difficult to source QPs with the relevant experience to go directly on to their licence.
Consequently, employers are normally dependent on transitional QP, contractors and those who
have been trained internally.
Several respondents described the difficulty of finding QPs with experience in novel areas.
‘I don’t think there are enough QPs with prior experience in sterile manufacture advanced therapy
products. Nor do I think there are enough QPs who are prepared to think outside the box (Head of
Production for novel IMP manufacturing facility).’
‘We manufacture IMP and so to get a QP with that level of experience is very rare so we have to train
them when we get them on site (QP for multinational pharmaceutical company).’
‘I think some of the older QPs around would baulk at dealing in this area. I know one or two of them
wouldn’t touch this with a barge pole, as in advanced therapies, because they don’t understand the
risk (QP for NHS unit A).’
All respondents expressed that to varying extents it would be difficult to find a QP to go directly on
to their licence, but those producing IMPs described particular issues relating to the actual level of
experience that is required. Two respondents said that filling the gap with contractors also presents
challenges, given that they too can be unfamiliar with the particular areas of working. This was put
most starkly by the QP for a novel manufacturing facility.
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‘You may only ever make one batch of one product, therefore everything is new. Everything is
different. The two contract QPs we have on our licence, one is actually an assessor to the Society of
Biology and the other one is with 30-40 years of experience, and I’ve actually had to hold their hands
on all occasions to take them through the processes we use.’
As such, these types of manufacturing organisations, whilst still relying on contractors to some
extent, are heavily dependent on those who achieved Qualified Persons status under the transitional
arrangements for investigational medicinal products, and training QPs internally. Transitional QPs
will inevitably retire at some point and so succession planning from within becomes ever more
important for covering long term demand. As discussed earlier, however, the breadth of knowledge
required for QP certification may also be having a limiting effect on the ability of those producing
IMPs to train QPs, further compounding the problem.
The difficulties for manufacturers of IMPs can also be exacerbated by the fact they are often SMEs or
NHS units, meaning that they have fewer resources to attract QPs or to pay for contractors. Out of
the 7 organisations manufacturing IMPs who took part in this study, there were 3 NHS units, 3 SMEs
and 1 larger company, suggesting that problems described above can be aggravated by the limited
resources associated with SMEs and publically funded organisations.
It is clear from the findings that there are many complications for those sourcing QPs in more
novel and innovative areas. In particular, respondents generally found it difficult to find QPs with
relevant experience. Transitional QPs are helping to meet current demand, but as these QPs retire
there will be ever more need for succession planning from within. That being said, the
requirement for trainee IMP QPs to acquire a wide breadth of knowledge in areas outside of their
usual remit, presents a further obstacle.
17. QPs in the EU (outside of the UK)
Routes to increasing supply with non-UK QPs from elsewhere in the EU are not popular. QPs from
outside of the UK tend to have fewer management skills and less industrial technical skills.
Interpretation of the EU directives differs between EU countries, and Germany was cited by several
respondents as an example where regulation is not stringent enough.
‘It’s crazy the system they have in Germany. Where all you need is Quality Control experience and
you can become a QP at the plant, so you just don’t have the knowledge and experience to do it.’
It might be argued that Germany is an extreme example, and given the capacity for differing
interpretations the UK may look to reduce the stringency of its guidance. One respondent said that
while extra requirements have been added to the Study Guide, it is seldom the case that
requirements are removed. Most respondents, however, felt that it was right that the certification
process is vigorous because the quality of UK QPs is very high, despite the low numbers being
certified by the professional bodies. In the long term, this could give the UK a comparative
advantage with the rest of Europe, in terms of effective quality control.
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18. Summary
The following section will use the above discussion to provide summary answers to the four original
research questions.
I. What broadly is the size of the QP workforce in the UK?
a. Data supplied by the MHRA suggest that the number of licences requiring a QP is fairly balanced
to the number of QPs identified on licences. However, given the complexities of mapping
individuals to licences and licences to sites it has not been possible to determine whether there
are actually an adequate number of certified QPs to fill the required posts.
b. This paper would suggest further research in this area in order to build on the qualitative
findings laid out in this study.
II. How difficult is it to recruit or contract QPs?
a. All respondents indicated to varying extents that it would be difficult, although not impossible,
to source a QP to go directly on to their licence. Employers normally opt to employ contractors
or to train internally in response to this difficultly.
b. Contractors are normally available to fill gaps in recruitment or to work on specific projects.
Flexibility to cover specific projects in this way was seen as a major advantage in enabling cost
effective employment of contractors for short periods of time.
c. This study identified particular recruitment difficulties for NHS manufacturing units and
organisations producing IMPs. It was suggested that NHS manufacturing units are unable to
offer competitive salaries that will attract suitably experienced QPs from industry. Furthermore,
organisations producing Investigational Medicinal Products often rely on transitional QPs given
the difficulty in finding QPs with the relevant experience in niche areas.
III. How do the requirements for QP certification affect the supply of QPs?
a. A small number of candidates are submitting applications. According to one consultant
interviewed, there has been an average of 44 vivas each year between 2003 and 2013, with a
pass rate of 68%. Over the last 5 years of this period this has fallen to 41 applications per year
and a pass rate of 63%
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b. Certification rate of around 30 per year is low (4% of the number currently identified on
Licences)
c. The role of QP requires someone with fastidious attention to detail, but who can also negotiate
effectively with senior staff to find creative, yet compliant, solutions to short term production
issues. This combination of qualities can be difficult to find. In any event, good sponsors are also
required to mentor good candidates in order to develop these qualities
d. Training takes from three to five years, and can cost from £30,000 to £50,000 for the complete
class room based learning component. As a consequence there are both professional and
financial pressures to pass at the first attempt. This may make the role less attractive to
otherwise good, but often risk-averse, candidates. While training capacity does not seem to be
a restriction, with providers adding and removing courses in response to demand, cost is
frequently cited as a significant barrier. Employers are reluctant to invest in training and
sponsoring potential QPs, as there is a high prevalence of newly qualified QPs leaving the
business as soon as they qualify. This has resulted in some employers introducing a claw back
system to incentivise QPs to stay with the business for a specified time after qualifying.
e. Sponsors were found to lack awareness of their responsibilities, and in turn, do not engage fully
in the process. It was suggested that part of the difficulty comes from the fact that sponsors are
selected on a voluntary basis, with no formal requirements in place for who can fulfil this
position. It is important to note that the ‘Guidance for Applicants and Sponsors’ does contain
detailed information, although the requirements are not mandated. It was also suggested that
some sponsors simply do not read the guidance, which clearly leads to confusion over
responsibilities.
f. Gaining relevant experience is a near universal limiting factor, more so for niche areas.
g. The assessment process has a reputation for being excessively wide ranging, difficult to pass
and expensive to retake. Experience is required in areas where there is no intention to practice.
Several respondents suggested that this could be reviewed by the regulator. The regulatory
position is that the certification process is designed to produce all-round QPs who are able to be
employed on any licenced site, and so revisions to the requirements would be inappropriate.
h. In the past, the large body of QPs certified under transitional arrangements has limited the
pressure on employers to provide sponsorship and funding for trainees.
IV. What are the barriers to recruitment?
a. Contract employment is far more lucrative and/or involves shorter hours. Qualified QPs have
salaries around £50,000 while QPs working under contract can earn in excess of £80,000 per
year. The attraction of permanent positions is clearly limited within this context.
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b. The amount of evidence of relevant training and experience that is required before allowing
QPs to be named on licences has increased over recent years. One interviewee observed that
while extra requirements have been added, it is seldom if ever the case that requirements are
removed.
c. Employers themselves can also expect QPs to have a level and duration of experience that goes
beyond that dictated in the Study Guide.
d. The knowledge requirements contained within the Study Guide were criticised as being too
wide ranging for those who were planning to be employed in a particular area of
pharmaceutical activity, further compounding the difficulty for IMP manufacturers to acquire
suitable QPs. It was proposed that a more bespoke approach could be applied, so that those
attempting to qualify as a QP for IMPs would be required to just have relevant knowledge and
experience in that particular area.
One aspect that is potentially tractable is to allow for something closer to bespoke training and
assessment. This would not necessarily involve diluting requirements, but serve simply to
increase specificity of training. By focussing on formal teaching and operational experience
relevant to a particular QP post, there may be benefits in:
• Reducing formal training costs
• Reducing the cost and difficulty in obtaining operational experience
• Improving the attractiveness of the role to potential candidates
• Reducing in the time taken to qualify.
19. Concluding remarks
The conclusions drawn from this paper must acknowledge that the survey was of a small number of
interested parties and very much of a qualitative nature. Despite this, respondents had considerable
collective experience of the industry; as QPs, recruiters, trainers, assessors and sponsors. Their views
formed an essentially consistent picture of a sector that is today broadly able to match QPs to
licences, but with some serious difficulties for niche areas and small manufacturing units (including
within hospitals). The evolution of the industry in the UK will make this issue increasingly acute, as
the number of small units, generating innovative products, grows.
The rate at which new QPs are being certified by the professional bodies is a concern, and one only
exacerbated by the loss of transitional QPs in the coming years. Overall, respondents reported that
they felt it would be difficult to source QPs to go directly on to their licence, although not impossible
in all cases. In response to this difficulty, employers are opting to contract QPs or train internally,
but the costs associated with this are substantial.
Page 26 of 29
APPENDIX A
Interviewee- Director of Compliance
Organisation- Large multinational company who provide services ranging from drug discovery to
development to major pharmaceutical companies. They produce a wide range of pharmaceuticals,
including hard gels, tablets and injectables
Size- 1000 employees at UK site
Interviewee- QP Consultant A
Organisation- Quality Consultant for IMP and commercial products
Size- 1 employee
Interviewee- QP training Consultant
Organisation- Consultancy providing Pharmaceutical Industry Training and Mentoring for Trainee
Qualified Persons & their sponsors
Size- 1
Interviewee- QP for NHS unit A
Organisation- NHS Unit specialising in blood, tissue and organs. Is involved in cellular therapies
which become ATMPs, gene therapies and IMPs
Size- 30
Interviewee- Head of Production at NHS manufacturing Unit
Organisation- NHS manufacturing unit in sterile, non-sterile, aseptic manufacture. Site also has an
IMP licence and so deals with clinical trial licence manufacturing, packaging and distribution
Size- 40
Interviewee- QP for contract manufacturing facility
Organisation-Contract manufacturing facility producing IMPs
Size- 150
Interviewee- Director of Quality
Organisation- Branch of a multinational pharmaceutical company
Size-550 on site
Page 27 of 29
Interviewee- QP for Viral Vaccine manufacturer
Organisation-Pharmaceutical Manufacturer of viral vaccine
Size- 85-90 on site
Interviewee- QP for novel IMP Manufacturing facility & Head of Production for novel IMP
manufacturing facility
Organisation- Manufacturing facility for producing novel IMPs for clinical trial
Size- 16 on site
Interviewee- NHS Assessor
Organisation- NHS
Size- N/A
Interviewee- Head of HR
Organisation- Pharmaceutical company working manufacturing a range of dosage forms
Size- 200
Interviewee- Chief Operating Officer
Organisation- Contract Manufacturing Organisation for ATMPs & IMPs
Size- 25
Interviewee- QP for NHS Unit B
Organisation- NHS manufacturing unit producing Aseptic creams and liquids
Size- 800
Interviewee- Lead QP for trial material
Organisation- Research and Development site
Size- unknown
Interviewee- QP for Contract Packager
Organisation- Large multinational contract packaging service, which supports customers at each
stage of the development and commercialisation of drug products
Size- 320
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Interviewee- Managing Director
Organisation- Group that operate a number of pharmaceutical companies, including a company that
specialises in the development and contract manufacture of pharmaceutical, semi-solid, liquid and
aerosol dose forms
Size- 250 working in Pharmaceuticals
Interviewee- QP trainer
Organisation- Training organisation for global food, drink, pharmaceutical, healthcare,
biopharmaceutical and consumer goods sector, which runs a QP training course
Size- unknown
Interviewee- Director of Quality
Organisation- Manufacturer of Cannabis based non-herbal products, which include oral liquids,
solid doses, and non-steriles
Size- 210
Interviewee- Course Director for QP training course
Organisation- Training course within Pharmacy department at London University
Size- Unknown
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APPENDIX B
ATMPs- Advanced Therapy Medicinal products
CMOs- Contract Manufacturing Organisations
IMPs- Investigational Medicinal Products
ManA- Manufacturing Importation Authorisation (veterinary products)
ManSA- Manufacturing ‘specials’ Authorisation
MHRA- Medicines and Healthcare Products Regulatory Agency (MHRA)
MIA- Manufacturing Importation Authorisation
MIA(IMP)- Manufacturing Importation Authorisation (Investigational Medicinal Products)
MS- Manufacturer ‘specials’ Authorisation
QA- Quality Assurance
QP- Qualified Person
VMD- Veterinary Medicines Directorate
785 active Qualified Persons in the UK
Contract QPs are useful for short term demand or
specific projects
Direct recruitment is often challenging
Experience required for QP certification is extensive
and difficult to schedule with existing operational demands
IMP manufacturing units face difficulty sourcing QPs with relevant experience in novel
and innovative biologics
Wide ranging knowledge requirements are considered inflexible and too
demanding for those attempting to qualify as an Investigational
Medicinal Products (IMPs) QP
Average of 1.4 QPs for each Manufacturing licence, 30% to 50%
of active QPs registered under Transitional arrangements
An average of 44 vivas are held each year with fewer than two thirds passing the exam
Employers are reluctant to make a large investment of
between £30,000 and £50,000 for classroom training
Budget constraints and uncompetitive salary banding are the main barriers to direct
recruitment in the NHS
Qualified Persons in Medicine ManufacturingThese findings are based on research conducted with 20 representatives from the Medicine Manufacturing industry. The aim of the study was to understand more about what barriers exist for the recruitment of Qualified Persons (QPs), and how these barriers are distributed across different manufacturing areas.
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